12 results
The primary goal of this study is to investigate the effect of low doses of mirtazapine and quetiapine on sleep, assessed using polysomnography and subjective sleep measures, of healthy subjects whose sleep will be disturbed by auditory stimuli (…
The primary study objectives are as follows:-To evaluate the pharmacokinetics (PK) of golimumab in pediatric subjects aged 2 through 17 years with moderately to severely active UC.-To evaluate the safety of golimumab in pediatric subjects aged 2…
Primary study objective Is the reduction of 1 to several antipsychotic antipsychotic associated with more relapse? Relapse is measured with the Brief Psychiatric Rating Scale (BPRS) and is defined as: - An absolute increase of> 2 on one of…
Primary ObjectivesThe primary objective is to assess the efficacy (primarily through time to relapse) of long-acting injectable (LAI) paliperidone palmitate compared to treatment as usual with orally administered antipsychotics in monotherapy over…
Our main aim is to evaluate the effectiveness and cost-effectiveness of two tapering strategies:(i)DMARD tapering and (ii)anti-TNF tapering in RA patients with DMARD&anti-TNF(etanercept, adalimumab, certolizumab or golimumab) induced…
Until recently there were only few therapeutic options to treat AS. Efficacy is proven for several tumor necrosis factor (TNF)-blocking agents, including golimumab. 2-8 However, up to now, the efficacy of golimumab treatment on EAMs, like anterior…
The purpose of this study is to investigate the safety and tolerability of different doses of neosaxitoxin when it is administered to healthy male volunteers alone and in combination with bupivacaine (with and without epinephrine) in perineural…
Primary objectives and hypotises: In adults with active nr-axSpA who attain inactive disease after receiving open-label golimumab during a 10-month run-in (Period 1):Primary Objective: To evaluate the effect of treatment withdrawal vs continued…
To investigate whether tapering MTX first, then the TNFi golimumab (GOL), is more efficacious than tapering GOL first, then MTX, in sustaining remission and reaching drug free remission.
The aim of this study is to describe pharmacokinetic parameters of the following golimumab regimens: 50 mg every month, 100 mg every one-and-a-half month and 100 mg every two months, in patients with a rheumatic disease.
1) to demonstrate the safety and efficacy of golimumab + MTX versus MTX alone in DMARD naïve PsA patients2) to demonstrate that golimumab + MTX is superior to MTX alone to achieve low to very low disease activity in DMARD naïve PsA patients3) to…
Primary objective:The primary objective of this study is to evaluate the efficacy of flexibly dosed esketamine nasal spray compared with quetiapine extended-release(XR), both in combination with a continuing selective serotonin reuptake inhibitor (…